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From PDUFA Dates to Phase Data — We Track What Moves the Stock

Every biotech catalyst that matters — FDA dates, trial data, and what it actually means for the stock.

We track every PDUFA date, clinical trial readout, and FDA advisory committee meeting. We break down what the science means in plain English — no PhD required. If it moves a biotech stock, we're on it.

See the FDA Calendar →

Markets at a Glance

12
PDUFA dates in next 90 days
Oncology dominates the calendar
6
Advisory committee meetings
Through October 2026
$4.2B
Biotech IPO proceeds YTD
Across 18 pricings
Oncology
Hottest sector
Checkpoint inhibitors, CAR-T, ADCs

Top Stories

FDA Calendar — PDUFA Dates, Advisory Panels, Trial Readouts

The next FDA approval date is 14 days away. Here's what's on the calendar and who it moves.

Open the calendar →

Latest News

Sep 25 Ionis' Ulefnersen Hits Primary Endpoint in Phase 3 FUSION Trial for FUS-ALS IONS breaking Sep 25 MIRM Atebrioz Approved for FOP, First ALK2 Inhibitor Clears One Day Early MIRM breaking Sep 25 Merck, Daiichi Withdraw I-DXd BLA in SCLC After FDA Flags Phase 2 Data MRK breaking Sep 24 Celldex's Barzolvolimab Hits Both Phase 3 Hives Trials; Anaphylaxis Cases Clip the Stock CLDX breaking Sep 9 FDA Approves AstraZeneca's Etcamah for ESR1-Mutant Breast Cancer, Overriding Its Advisory Panel AZN breaking

Featured Sectors

Oncology

Checkpoint inhibitors, CAR-T cell therapies, and antibody-drug conjugates driving the next wave of approvals.

Gene Therapy

CRISPR, base editing, and AAV-delivered one-time treatments — binary risk, massive upside if they work.

mRNA

Beyond COVID: mRNA platforms expanding into oncology, rare disease, and personalized vaccines.

Rare Disease

Orphan drug designations, ultra-rare indications, and the pricing power that comes with tiny patient populations.

Neuroscience

Alzheimer's, Parkinson's, and ALS — historically the graveyard of biotech, but new mechanisms are showing promise.

Infectious Disease

Vaccines, antivirals, and antibiotics. Pandemic preparedness funding is a new tailwind.